Abstract
Patient information leaflets (PILs) serve as users’ sources of legitimate information on medicine administration, safety and side effects. Far from being mere reference material, PILs guide consumers to make informed healthcare decisions. This means that PILs become controversial when they do not deliver comprehensive information and can thus be a source of confusion to patients (Zethsen, 2022). As such, PILs should balance two complementary and opposing requirements. On the one hand, they must meet the needs of user-friendliness for a diastratically heterogeneous audience, on the other hand, they must comply with scientific accuracy and a set of stringent criteria established by current regulations (Gotti, 2016). Nevertheless, expectations on PILs are often disregarded by some pharmaceutical companies (Medina-Córdoba et al., 2021) as the results seem to fall short of the intended lay- friendliness targets (Fage-Butler, 2013; Okoro, 2022). As a unidirectional form of communication, PILs lack immediate clarification options, leaving patients reliant on healthcare professionals for explanations. Misunderstandings can undermine medication adherence and compliance (Albert et al., 2014).This study employs a corpus-based approach (McEnery, Xiao & Tono, 2006; Tognini-Bonelli, 2001) to examine four corpora with the aim of identifying linguistic features that affect the accessibility of PILs in British and Italian contexts. The corpora comprise PILs from top-selling over-the-counter (OTC) and prescription medications in both Italy and the UK. A combination of quantitative and qualitative analyses is conducted to investigate key linguistic features, including modality, passive voice, conditionals, negation, and specialized medical terminology, as these features have been identified in the literature on medical linguistics as factors that may present interpretative challenges for patients (Raynor et al., 2007; Pander Maat & Lentz, 2010).
The findings reveal that PILs in both linguistic contexts exhibit a pervasive presence of grammatical and lexical features that potentially heighten the cognitive effort required for patients to comprehend these documents. This is particularly true for the Italian PILs where these features stand out. Furthermore, the typology of drugs under consideration influences the nature of language use, with prescription medication PILs generally exhibiting a higher degree of specialized terminology compared to OTC products. However, OTC PILs present a higher proportion of undisclosed terms, which may further challenge patient comprehension and accessibility.
EU and UK regulations must be improved with linguistic recommendations to enhance PIL accessibility and to reconcile regulatory compliance with patient-centered communication. This research project offers linguistic guidelines for achieving this balance. Future studies should adopt an interdisciplinary approach, involving linguists, healthcare professionals, and regulatory authorities to further refine PILs and ensure their broader accessibility.
Keywords: patient information leaflets, corpus lingu
| Date of Award | 24 Apr 2025 |
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| Original language | English |
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| Supervisor | Lee Oakley (Supervisor), Marie McCullagh (Supervisor) & Alessia Tranchese (Supervisor) |